Synthetic Human Secretin in Children With Autism - Tabular View

Tracking Information
First Received Date ^ICMJE	May 8, 2002
Last Updated Date	August 4, 2005
Start Date ^ICMJE	April 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00036244 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Synthetic Human Secretin in Children With Autism
Official Title ^ICMJE	A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Efficacy, Safety and Tolerability of RG1068 (Synthetic Human Secretin) in Children With Autism
Brief Summary	The purpose of the study is to determine whether multiple doses of secretin are safe and effective in the treatment of children with autism.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Condition ^ICMJE	Autism
Intervention ^ICMJE	Drug: RG1068 (Synthetic Human Secretin)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	January 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	Autism
Gender	Both
Ages	32 Months to 59 Months
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00036244
Responsible Party
Study ID Numbers ^ICMJE	RG1068-04
Study Sponsor ^ICMJE	Repligen Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Repligen Corporation
Verification Date	August 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP